The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Crp-lex System: C-reactive Protein Antigen Detection In Serum: Slide Agglutnation Latex Test.
| Device ID | K972160 |
| 510k Number | K972160 |
| Device Name: | CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | TRINITY LABORATORIES, INC. 7517 PRECISION DR., #107 Raleigh, NC 27613 |
| Contact | Bruce A Clinton |
| Correspondent | Bruce A Clinton TRINITY LABORATORIES, INC. 7517 PRECISION DR., #107 Raleigh, NC 27613 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-09 |
| Decision Date | 1997-08-01 |